Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Completed · Phase 3 · Has a placebo group
Conditions studied: Attention Deficit/Hyperactivity Disorder
In brief
This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).
Key facts
- Study ID
- NCT01259492
- Run by
- Novartis Pharmaceuticals
- People needed
- 725
- Starts
- 2010-11-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2014-10-07
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
- Female patients of childbearing potential must be practicing an acceptable method of contraception.
You may not qualify if…
- Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
- History of alcohol or substance abuse within the last six months.
- History of seizures or use of anticonvulsant medication.
- Any psychiatric condition that requires medication or may interfere with study participation.
- Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
- Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
- Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
- Diagnosis or family history of Tourette's syndrome
- Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Novartis Investigative Site — Beverly Hills, California, United States
- Novartis Investigative Site — Spring Valley, California, United States
- Novartis Investigative Site — Bradenton, Florida, United States
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Orlando, Florida, United States
- Novartis Investigative Site — West Plam Beach, Florida, United States
- Novartis Investigative Site — Libertyville, Illinois, United States
- Novartis Investigative Site — Owensboro, Kentucky, United States
- Novartis Investigative Site — Troy, Michigan, United States
- Novartis Investigative Site — Las Vegas, Nevada, United States
- Novartis Investigative Site — Las Vegas, Nevada, United States
- Novartis Investigative Site — Willingboro, New Jersey, United States
- Novartis Investigative Site — Fargo, North Dakota, United States
- Novartis Investigative Site — Columbus, Ohio, United States
- Novartis Investigative Site — Oklahoma City, Oklahoma, United States
- Novartis Investigative Site — Philadelphia, Pennsylvania, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Bellevue, Washington, United States
- Novartis Investigative Site — Seattle, Washington, United States
- Novartis Investigative Site — Bruges, Belgium, Belgium
- Novartis Investigative Site — Heusden-Zolder, Belgium, Belgium
- Novartis Investigative Site — Kortenberg, Belgium, Belgium
- Novartis Investigative Site — Uccle, Belgium, Belgium
- Novartis Investigative Site — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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